Phase III Randomized, Double-Blind, Placebo-Controlled Study of Dehydroepiandrosterone in Women With Active Systemic Lupus Erythematosus
dehydroepiandrosterone
Enfermedades Autoinmunes+8
+ Infecciones
+ Enfermedades de las Articulaciones
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de marzo de 1996
Fecha en la que se inscribió al primer participante.PROTOCOL OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomly assigned to daily oral dehydroepiandrosterone or placebo for 52 weeks. Patients are evaluated every 13 weeks on study and return for a follow-up 6 weeks after completion of therapy. Concurrent therapy with estrogen replacement and stable doses of prednisone, azathioprine, methotrexate (with folate supplementation), hydroxychloroquine, and nonsteroidal anti-inflammatory drugs is allowed. Other investigational medications and immunosuppressants are prohibited.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 300 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Mujer
Sexo biológico de los participantes elegibles para inscribirse.A partir de 18 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos no permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Systemic lupus erythematosus by 1982 American College of Rheumatology criteria Diagnosed for at least 6 months Systemic Lupus Activity Measure score at least 7 Points for erythrocyte sedimentation rate excluded SLEDAI score of greater than 2 at both screening and qualifying visits --Prior/Concurrent Therapy-- No prior participation in any dehydroepiandrosterone (DHEA) study No investigational agent within the longer of 30 days or 10 half-lives of the agent Prednisone (or equivalent) dose 0 to 10 mg/day Unchanged for at least 6 weeks prior to entry At least 3 months since immunosuppressants other than azathioprine and methotrexate, including: DHEA Adrenocorticotropin hormone Androgens Cyclophosphamide Cyclosporine Immune globulin At least 6 weeks since change in azathioprine, methotrexate, or hydroxychloroquine --Patient Characteristics-- Renal: No requirement for hemodialysis Cardiovascular: No serious abnormality on electrocardiogram Other: No hypersensitivity to DHEA or inactive ingredients in GL701 formulation, i.e., cornstarch, lactose, or magnesium stearate No history of breast cancer or reproductive tract malignancy Cervical carcinoma eligible if surgically cured, i.e., no evidence of disease for 5 years No condition that would prevent compliance or follow-up, e.g.: Alcoholism Drug addiction Acute withdrawal from chemical dependency Psychiatric disease No pregnant or nursing women Negative pregnancy test required of fertile women Reliable contraception required of fertile women No estrogen-containing oral contraceptives on study At least 3 weeks since estrogen-containing oral contraceptives